CancerNCT06243107
Promoting the Application of Tai Chi to Improve the Fatigue in Cancer Patients
A study testing Tai-chi in people with Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Cancer patients often experience Cancer-Related Fatigue (CRF) due to surgeries, radiation therapy, and/or chemotherapy. CRF does not improve with sleep or rest and not only affects daily activities but can also significantly reduce quality of life. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Tai-chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20 years or older;
- Diagnosed with tumors and receiving radiation therapy, chemotherapy, or concurrent chemoradiotherapy.
- Able to communicate and cooperate with the executing team.
- Willing to participate in this study.
Who cannot join
- Diagnosed with severe internal medical conditions, multiple myeloma, or skeletal metastases.
- Evidence of medical contraindications for exercise.
- Regularly practicing health-preserving exercises or other forms of physical activity.
- Communication barriers, unable to cooperate with the execution of actions.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taoyuan Chang Gung Memorial Hospital
Taoyuan, No.123,Dinghu Rd.,Guishan Dist, 326
About this study
Official title: The Effectiveness of Tai-Chi in Cancer Patients Improves Fatigue, Mood, Sleep, Quality of Life and Heart Rate Variability
Cancer patients often experience Cancer-Related Fatigue (CRF) due to surgeries, radiation therapy, and/or chemotherapy. CRF does not improve with sleep or rest and not only affects daily activities but can also significantly reduce quality of life. Therefore, finding ways to alleviate fatigue is crucial for cancer patients. Literature indicates that exercise has demonstrated effectiveness in reducing fatigue. Qigong/Tai Chi, based on movement, is a traditional Chinese mind-body practice falling within the range of low to moderate-intensity aerobic exercise. There is no consistent consensus on the effectiveness and frequency of Qigong/Tai Chi for CRF in different cancer patients. Hence, this study aims to investigate through empirical nursing procedures whether "the practice of Qigong/Tai Chi by cancer patients can improve participants' fatigue. Researchers hope that the results of this study can serve as a reference for future clinical applications in alleviating fatigue among cancer patients.
Read the detailed description
Cancer has consistently ranked as the leading cause of death in Taiwan since 1982. Cancer patients undergo a series of medical treatments, including surgery, radiation therapy, and chemotherapy. Apart from the disease itself, the medical procedures associated with cancer often bring significant physiological, psychological, and emotional stress to the patients. Furthermore, Cancer-Related Fatigue (CRF) is the most common and persistent discomfort experienced by cancer patients. CRF is a prolonged subjective feeling of fatigue or exhaustion that does not improve with sleep or rest. Over 50% of cancer patients report that fatigue reduces participants' physical activity, affects participants ability to perform tasks, and disrupts participants' daily lives, ultimately leading to a diminished quality of life. Among non-pharmacological approaches to managing CRF, exercise has garnered the most research support and demonstrated efficacy. Despite potential limitations on exercise capacity due to the disease, studies have shown that patients, particularly during the initial diagnosis, surgery, or during radiation and chemotherapy, can alleviate CRF and improve participants' overall health through exercise.
Traditional Chinese Exercise and Health Preservation involves using techniques that regulate the mind, breath, and body to promote sufficient qi and blood circulation, unobstructed meridians, and harmonized organ functions. It is a traditional health preservation method aimed at enhancing physical fitness and preventing diseases. Tai Chi, a form of TCEHP, is simple to learn, with minimal space requirements. Through an evidence-based approach and a comprehensive review of two articles, it was found that intervention with Tai Chi for a duration of over 8 weeks, with at least 180 minutes per week, effectively alleviates fatigue in breast cancer and lung cancer patients. It also demonstrated positive effects on fatigue levels in head and neck cancer patients undergoing concurrent chemoradiotherapy (CCRT). Given our institution's diverse cancer patient population, primarily comprising head and neck, breast, and gastrointestinal cancer patients, Researchers plan to proceed with the fourth and fifth steps of the evidence-based practice to apply the evidence to patients and evaluate the care outcomes.
Therefore, the objectives of this study are as follows:
To promote the evidence-based application of Tai Chi for cancer patients to improve fatigue.To promote the evidence-based application of Tai Chi for cancer patients to improve sleep quality.
To promote the evidence-based application of Tai Chi for cancer patients to alleviate anxiety and depression.
To promote the evidence-based application of Tai Chi for cancer patients to enhance quality of life.
To promote the evidence-based application of Tai Chi for cancer patients to assess its impact on heart rate variability.
- Conditions
- Cancer
- Being tested
- Tai-chi
- Keywords
- cancer, Fatigue, negative mood, quality of life, Sleeping quality
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai-chiBehavioural
Participants will each receive a Tai Chi manual and have access to an instructional audio-visual material via a QR code. The instructional material is tailored specifically for cancer patients. Participants will receive individualized guidance and instructions from the researcher (YH) until they have completed all the executions on the checklist to the required standards.
| Study group | Role | What they receive |
|---|---|---|
| Tai-chi | Experimental | Tai Chi Chuan Intervention: There are 10 styles ,Each movement is performed for 3 minutes, repeated 10 times, totaling 30 minutes per session. participants will engage Tai Chi practice six times a week for eight weeks. Receives: Behavioral: Tai-chi |
| control | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
brief fatigue inventory
Mendoza et al. developed the Brief Fatigue Inventory (BFI) in 1999 to rapidly assess the level of fatigue in cancer patients. This scale comprises nine questions. The first three questions assess the level of fatigue, including current fatigue, typical fatigue over the past 24 hours, and worst fatigue over the past 24 hours. The remaining six questions assess the impact of fatigue on daily life over the past 24 hours, covering general activities, mood, walking ability, daily work (including work outside the home and household chores), interaction with others, and enjoyment of life. Scores range from 0 to 10, where 0 indicates no fatigue, and 10 represents the worst imaginable level of fatigue. The scores for the nine questions are then summed and averaged, with higher scores indicating higher levels of fatigue and a more significant impact on daily life.
Regenerate
Measured: At enrollment, during the first week, second week, fourth week, and eighth week.
Secondary outcomes (4)
Pittsburgh Sleep Quality Index
This scale, developed by Buysse et al. in 1989, is a self-administered questionnaire used to assess the sleep patterns of respondents over the past month. The scale consists of seven monitoring items, including sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item is rated on a four-point Likert scale. The questionnaire score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality. A PSQI score greater than 5 indicates poor sleep quality. The scale has been translated into Chinese by Wang Runqing. The English version demonstrates a Cronbach's alpha reliability coefficient of .75."
Measured: t enrollment, during the first week, second week, fourth week, and eighth week
Hospital Anxiety and depression Scale
This scale, developed by Zigmond and Snaith (1983), is primarily designed to measure anxiety and depression in general clinical populations for assessing the severity of emotional disorders. The Hospital Anxiety and Depression Scale (HADS) utilizes a 4-point scoring system, separate scoring for anxiety and depression, and consists of a total of 14 items, with 7 assessing anxiety and 7 assessing depression. The scores for both domains range from 0 to 21 points. Scores less than 7 indicate the absence of anxiety or depression. Scores between 8 and 10 suggest borderline or suspected cases. Scores equal to or greater than 11 indicate the presence of anxiety or depression. This scale is frequently used in research involving cancer patients. The internal consistency reliability for this scale, measured using Cronbach's alpha, is 0.85 for anxiety and 0.81 for depression."
Regenerate
Measured: enrollment, during the first week, second week, fourth week, and eighth week
FACIT-G quality of life
"This study utilized the FACIT-G scale for self-reporting and design, although it can also be administered through interviews. The scale is structured around four factors: 'Physical Well-being,' 'Social/Family Well-being,' 'Functional Well-being,' and 'Emotional Well-being.' The scale includes two subscales, 'Emotional Well-being' and 'Social/Family Well-being,' and all subscale items contribute to the total score, which represents the sum of subscale scores. For all FACIT scales and symptom indices, a higher score indicates a better quality of life. The Cronbach's alpha for the entire range is 0.89
Measured: enrollment, during the first week, second week, fourth week, and eighth week
Heart rate variability
The study utilized a Heart Rate Variability (HRV) monitor (Model: 8Z11, WeGene Corporation, Ministry of Health and Welfare Medical Equipment No. 004896, Taiwan) to measure HRV parameters. This device measures and records electrocardiograms, and calculates heart rate, standard deviation, and mean value using each RR interval. Subsequently, it performs frequency domain analysis to derive HRV parameters, including standard deviation of normal-to-normal intervals, low-frequency power, high-frequency power, and the ratio of low-frequency to high-frequency power.
Measured: enrollment, during the first week, second week, fourth week, and eighth week."
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 May 2019
- Primary completion30 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental research
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsang-Tang MD Hsieh, PHD, Study director, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243107
- Sponsor's protocol ID
- 201900504B0
- Status last verified
- Oct 2023
- First submitted
- 25 Dec 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study aims to investigate the effects of Tai Chi intervention on fatigue, sleep quality, levels of anxiety and depression, quality of life, and heart rate variability between the Tai Chi group and the control group. The results of the data can be shared.
Publications
Wayne PM, Lee MS, Novakowski J, Osypiuk K, Ligibel J, Carlson LE, Song R. Tai Chi and Qigong for cancer-related symptoms and quality of life: a systematic review and meta-analysis. J Cancer Surviv. 2018 Apr;12(2):256-267. doi: 10.1007/s11764-017-0665-5. Epub 2017 Dec 8.
PubMed 29222705Zeng Y, Xie X, Cheng ASK. Qigong or Tai Chi in Cancer Care: an Updated Systematic Review and Meta-analysis. Curr Oncol Rep. 2019 Apr 6;21(6):48. doi: 10.1007/s11912-019-0786-2.
PubMed 30955106Li W, You F, Wang Q, Shen Y, Wang J, Guo J. Effects of Tai Chi Chuan training on the QoL and psychological well-being in female patients with breast cancer: a systematic review of randomized controlled trials. Front Oncol. 2023 May 1;13:1143674. doi: 10.3389/fonc.2023.1143674. eCollection 2023.
PubMed 37197428Song S, Yu J, Ruan Y, Liu X, Xiu L, Yue X. Ameliorative effects of Tai Chi on cancer-related fatigue: a meta-analysis of randomized controlled trials. Support Care Cancer. 2018 Jul;26(7):2091-2102. doi: 10.1007/s00520-018-4136-y. Epub 2018 Mar 21.
PubMed 29564620
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Tai-Chi in Cancer Patients Improves Fatigue, Mood, Sleep, Quality of Life and Heart Rate Variability
- ClinicalTrials.gov ID
- NCT06243107
- Acronym / sponsor ID
- 201900504B0
- Conditions
- Cancer
- Keywords
- cancer, Fatigue, negative mood, quality of life, Sleeping quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer patients often experience Cancer-Related Fatigue (CRF) due to surgeries, radiation therapy, and/or chemotherapy. CRF does not improve with sleep or rest and not only affects daily activities but can also significantly reduce quality of life. Therefore, finding ways to alleviate fatigue is crucial for cancer patients. Literature indicates that exercise has demonstrated effectiveness in reducing fatigue. Qigong/Tai Chi, based on movement, is a traditional Chinese mind-body practice falling within the range of low to moderate-intensity aerobic exercise. There is no consistent consensus on the effectiveness and frequency of Qigong/Tai Chi for CRF in different cancer patients. Hence, this study aims to investigate through empirical nursing procedures whether "the practice of Qigong/Tai Chi by cancer patients can improve participants' fatigue. Researchers hope that the results of this study can serve as a reference for future clinical applications in alleviating fatigue among cancer patients.
Detailed description
Cancer has consistently ranked as the leading cause of death in Taiwan since 1982. Cancer patients undergo a series of medical treatments, including surgery, radiation therapy, and chemotherapy. Apart from the disease itself, the medical procedures associated with cancer often bring significant physiological, psychological, and emotional stress to the patients. Furthermore, Cancer-Related Fatigue (CRF) is the most common and persistent discomfort experienced by cancer patients. CRF is a prolonged subjective feeling of fatigue or exhaustion that does not improve with sleep or rest. Over 50% of cancer patients report that fatigue reduces participants' physical activity, affects participants ability to perform tasks, and disrupts participants' daily lives, ultimately leading to a diminished quality of life. Among non-pharmacological approaches to managing CRF, exercise has garnered the most research support and demonstrated efficacy. Despite potential limitations on exercise capacity due to the disease, studies have shown that patients, particularly during the initial diagnosis, surgery, or during radiation and chemotherapy, can alleviate CRF and improve participants' overall health through exercise.
Traditional Chinese Exercise and Health Preservation involves using techniques that regulate the mind, breath, and body to promote sufficient qi and blood circulation, unobstructed meridians, and harmonized organ functions. It is a traditional health preservation method aimed at enhancing physical fitness and preventing diseases. Tai Chi, a form of TCEHP, is simple to learn, with minimal space requirements. Through an evidence-based approach and a comprehensive review of two articles, it was found that intervention with Tai Chi for a duration of over 8 weeks, with at least 180 minutes per week, effectively alleviates fatigue in breast cancer and lung cancer patients. It also demonstrated positive effects on fatigue levels in head and neck cancer patients undergoing concurrent chemoradiotherapy (CCRT). Given our institution's diverse cancer patient population, primarily comprising head and neck, breast, and gastrointestinal cancer patients, Researchers plan to proceed with the fourth and fifth steps of the evidence-based practice to apply the evidence to patients and evaluate the care outcomes.
Therefore, the objectives of this study are as follows:
To promote the evidence-based application of Tai Chi for cancer patients to improve fatigue.To promote the evidence-based application of Tai Chi for cancer patients to improve sleep quality.
To promote the evidence-based application of Tai Chi for cancer patients to alleviate anxiety and depression.
To promote the evidence-based application of Tai Chi for cancer patients to enhance quality of life.
To promote the evidence-based application of Tai Chi for cancer patients to assess its impact on heart rate variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Quasi-experimental research
| Arm | Type | Receives |
|---|---|---|
| Tai-chi | Experimental | Behavioral: Tai-chiTai Chi Chuan Intervention: There are 10 styles ,Each movement is performed for 3 minutes, repeated 10 times, totaling 30 minutes per session. participants will engage Tai Chi practice six times a week for eight weeks. |
| control | No intervention | –routine care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 20 years or older;
- Diagnosed with tumors and receiving radiation therapy, chemotherapy, or concurrent chemoradiotherapy.
- Able to communicate and cooperate with the executing team.
- Willing to participate in this study.
Key exclusion criteria (4 listed)
- Diagnosed with severe internal medical conditions, multiple myeloma, or skeletal metastases.
- Evidence of medical contraindications for exercise.
- Regularly practicing health-preserving exercises or other forms of physical activity.
- Communication barriers, unable to cooperate with the execution of actions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai-chiParticipants will each receive a Tai Chi manual and have access to an instructional audio-visual material via a QR code. The instructional material is tailored specifically for cancer patients. Participants will receive individualized guidance and instructions from the researcher (YH) until they have completed all the executions on the checklist to the required standards. | Behavioural | Tai-chi |
Primary outcome
brief fatigue inventory
Time frame: At enrollment, during the first week, second week, fourth week, and eighth week.
Mendoza et al. developed the Brief Fatigue Inventory (BFI) in 1999 to rapidly assess the level of fatigue in cancer patients. This scale comprises nine questions. The first three questions assess the level of fatigue, including current fatigue, typical fatigue over the past 24 hours, and worst fatigue over the past 24 hours. The remaining six questions assess the impact of fatigue on daily life over the past 24 hours, covering general activities, mood, walking ability, daily work (including work outside the home and household chores), interaction with others, and enjoyment of life. Scores range from 0 to 10, where 0 indicates no fatigue, and 10 represents the worst imaginable level of fatigue. The scores for the nine questions are then summed and averaged, with higher scores indicating higher levels of fatigue and a more significant impact on daily life. Regenerate
4 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: t enrollment, during the first week, second week, fourth week, and eighth week
Hospital Anxiety and depression Scale
Time frame: enrollment, during the first week, second week, fourth week, and eighth week
FACIT-G quality of life
Time frame: enrollment, during the first week, second week, fourth week, and eighth week
Heart rate variability
Time frame: enrollment, during the first week, second week, fourth week, and eighth week."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 29222705Wayne PM, Lee MS, Novakowski J, Osypiuk K, Ligibel J, Carlson LE, Song R. Tai Chi and Qigong for cancer-related symptoms and quality of life: a systematic review and meta-analysis. J Cancer Surviv. 2018 Apr;12(2):256-267. doi: 10.1007/s11764-017-0665-5. Epub 2017 Dec 8.
- Results publication: PubMed 30955106Zeng Y, Xie X, Cheng ASK. Qigong or Tai Chi in Cancer Care: an Updated Systematic Review and Meta-analysis. Curr Oncol Rep. 2019 Apr 6;21(6):48. doi: 10.1007/s11912-019-0786-2.
- Results publication: PubMed 37197428Li W, You F, Wang Q, Shen Y, Wang J, Guo J. Effects of Tai Chi Chuan training on the QoL and psychological well-being in female patients with breast cancer: a systematic review of randomized controlled trials. Front Oncol. 2023 May 1;13:1143674. doi: 10.3389/fonc.2023.1143674. eCollection 2023.
- Results publication: PubMed 29564620Song S, Yu J, Ruan Y, Liu X, Xiu L, Yue X. Ameliorative effects of Tai Chi on cancer-related fatigue: a meta-analysis of randomized controlled trials. Support Care Cancer. 2018 Jul;26(7):2091-2102. doi: 10.1007/s00520-018-4136-y. Epub 2018 Mar 21.
- Individual participant dataSharing planned: Yes. This study aims to investigate the effects of Tai Chi intervention on fatigue, sleep quality, levels of anxiety and depression, quality of life, and heart rate variability between the Tai Chi group and the control group. The results of the data can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsang-Tang MD Hsieh, PHD study director
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai-chi in people with Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brief fatigue inventory (time frame: At enrollment, during the first week, second week, fourth week, and eighth week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243107, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.